INTERVENTIONALCOMPLETEDNCT04228965

A Prospective Trial of Varenicline and Incentives for Tobacco Cessation in Adults

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication, varenicline, and financial incentives with tobacco users. The investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive tobacco cessation treatment (varenicline) for 12 weeks. This study will recruit adult tobacco users (ages 18-40) who are motivated to quit smoking cigarettes.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-06-15

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE4
Enrollment: 181 (ACTUAL)
Start date: 2020-01-28
Sponsor: Medical University of South Carolina
Design: NON RANDOMIZED · SINGLE GROUP · TREATMENT
Locations: 3
Results record: Present in registry snapshot

Cannabis co-use among tobacco users is exceedingly common and rates of co-use appear to be increasing among adults in the US, which is consistent with overall increases in cannabis use rates among US adults. Given the current cannabis landscape, further increases in cannabis use are likely and may result in continued increases in the co-use of cannabis and tobacco. Despite high rates of co-use, there is little consensus regarding treatment recommendations for this population and an understanding of the impact of co-use on successful cessation. The literature on the impact of co-use on tobacco cessation outcomes specifically has been mixed and fraught with limitations, including methodological variation, lack of biochemical verification to confirm cannabis use status and severity, and variations in study samples. Currently, no prospective studies have been conducted to evaluate the impact of cannabis use on tobacco cessation outcomes. Further, no studies have collected cannabis use changes during tobacco cessation treatment to assess for concurrent reductions, abstinence, or of greater concern, compensatory (i.e., increased) use as a result of tobacco reduction/abstinence. This study is a prospective 12-week tobacco cessation trial using established methods and outcomes typical of tobacco cessation trials, but specifically recruiting co-users of cannabis. The aims of this proposed study are to; 1) examine the impact of cannabis co-use on tobacco cessation outcomes among co-users compared to tobacco only participants (Aim #1), 2) among cannabis co-users, assess changes in cannabis use during tobacco treatment (Aim #2), and 3) assess for a dose-dependent impact of cannabis co-use severity on tobacco cessation (Exploratory Aim #1).

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Research network

Researchers and organizations

Erin A. McClure Kevin M. Gray Kyle J. Walters Matthew J. Carpenter Nathaniel L. Baker Rachel L. Tomko Medical University of South Carolina MUSC Hollings Cancer Center

Interventions

What was registered

DRUG

Varenicline

Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.

Chantix

BEHAVIORAL

Contingency Management

Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.

BEHAVIORAL

Counseling

Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.

Source-reported results

Results posted to the registry

2 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 1
Statistical analyses: 0
Adverse-event terms: 14

PRIMARYNumber of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12)

Time frame: Final 7 days of treatment (Week 12)
Measure: COUNT_OF_PARTICIPANTS · Participants
Reporting status: POSTED

7-day point prevalence abstinence from tobacco at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared between cannabis co-users and tobacco only controls.

Population: Estimation of the primary outcome was completed using 3 methods: 1) simple imputation (missing=smoking), 2) methods of multiple imputation, and 3) utilizing all available data (number analyzed is lower in each compared to imputation methods).

Group	N	Value	Spread / interval
Co-Use Group	110	30	-
Tobacco Only Group	71	40	-
Co-Use Group	110	36	-
Tobacco Only Group	71	42	-
Co-Use Group	110	30	-
Tobacco Only Group	71	40	-

SECONDARYCannabis Use During Tobacco Cessation Treatment (Among Co-users)

Time frame: Final 4 weeks of study treatment (Weeks 9-12)
Measure: GEOMETRIC_MEAN · urinary cannabinoids in ng/ml

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Not accepted

Inclusion criteria

1. Between the ages of 18 and 40 years old 2. Must be able to understand the study and provide written informed consent 3. Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day 4. Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit 5. Be interested in quitting smoking tobacco cigarettes (defined as a 5 or above on a 10-point Likert scale assessing interest in quitting \[1=not at all interested, 10=extremely interested\]) 6. Must be willing to take varenicline for the standard 12-week course of treatment 7. If female, agreement to use birth control (any form) to avoid pregnancy during study procedures Additional

Inclusion criteria

will be implemented for cannabis co-users, which include: 8. Self-reported use of cannabis on at least 10 out of the past 30 days or submit a positive qualitative urinary cannabinoid test at screening (limit of detection is 50 ng/ml)

Exclusion criteria

1. Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) or other significant concern in the past three months that may interfere with study performance, impact participant safety, compliance with study procedures, or potentially confound the interpretation of findings 2. Currently pregnant, lactating, or contemplating pregnancy in the next 6 months 3. Current use of medications with smoking cessation efficacy 4. Use of any medications that would interfere with varenicline 5. No regular use of other tobacco or nicotine products other than combustible cigarettes (e.g., smokeless tobacco, electronic cigarettes, etc.) in the past month prior to the quit attempt

primary outcomes

primary measures

Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12)

Time frame: Final 7 days of treatment (Week 12)

secondary outcomes

secondary measures

Cannabis Use During Tobacco Cessation Treatment (Among Co-users)

Time frame: Final 4 weeks of study treatment (Weeks 9-12)

Among cannabis co-users (n=110), cannabis use (based on urinary cannabinoids \[ng/ml\]) during the final 4 weeks of tobacco treatment (Weeks 9-12) will be assessed.

Publications

Locally readable linked articles

linked publication

Determining the impact of cannabis use and severity on tobacco cessation outcomes: study protocol for a prospective tobacco treatment trial.

BMC Psychology · Free full text

Snapshot provenance

Snapshot: 67768598-8192-40b8-bcb3-2c495b3e961a
Retrieved: 11/09/2026, 14:16:52
SHA-256: dc95f883b6c5c2ee116773c64957b6a87091617d00e48efb7d8c541fc9f2aa3a

Event	System	Groups: affected / at risk
Gastrointestinal Surgery	Surgical and medical procedures	Co-Use Group: 0 / 110 · Tobacco Only Group: 1 / 71
Altered State of Consciousness	Nervous system disorders	Co-Use Group: 1 / 110 · Tobacco Only Group: 0 / 71

Event	System	Groups: affected / at risk
Vomiting	Gastrointestinal disorders	Co-Use Group: 6 / 110 · Tobacco Only Group: 1 / 71
Nausea	Gastrointestinal disorders	Co-Use Group: 31 / 110 · Tobacco Only Group: 22 / 71
Irritability	General disorders	Co-Use Group: 10 / 110 · Tobacco Only Group: 3 / 71
Weight gain	Metabolism and nutrition disorders	Co-Use Group: 1 / 110 · Tobacco Only Group: 4 / 71
Headache	Nervous system disorders	Co-Use Group: 7 / 110 · Tobacco Only Group: 6 / 71
Somnolence	Nervous system disorders	Co-Use Group: 4 / 110 · Tobacco Only Group: 4 / 71
Vivid Dreams	Psychiatric disorders	Co-Use Group: 22 / 110 · Tobacco Only Group: 23 / 71
Depressed mood	Psychiatric disorders	Co-Use Group: 6 / 110 · Tobacco Only Group: 3 / 71
Insomnia	Psychiatric disorders	Co-Use Group: 6 / 110 · Tobacco Only Group: 5 / 71
Anxiety (Worsening)	Psychiatric disorders	Co-Use Group: 6 / 110 · Tobacco Only Group: 2 / 71
Tobacco Withdrawal Symptoms	Psychiatric disorders	Co-Use Group: 2 / 110 · Tobacco Only Group: 4 / 71
Vivid Dreams (Worsening)	Psychiatric disorders	Co-Use Group: 5 / 110 · Tobacco Only Group: 5 / 71

A Prospective Trial of Varenicline and Incentives for Tobacco Cessation in Adults

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

Researchers and organizations

What was registered

Varenicline

Contingency Management

Counseling

Results posted to the registry

Population and criteria

Inclusion criteria

Inclusion criteria

Exclusion criteria

primary measures

Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12)

secondary measures

Cannabis Use During Tobacco Cessation Treatment (Among Co-users)

Locally readable linked articles

Determining the impact of cannabis use and severity on tobacco cessation outcomes: study protocol for a prospective tobacco treatment trial.

Overall Study

Age, Continuous

Sex/Gender, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Cigarettes per day (assessed in the 30 days prior to screening/baseline))

Co-Use Group

Tobacco Only Group